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白内障手术中脉冲剂量二氟泼尼酯 0.05%与醋酸泼尼松龙 1%的多中心随机对照同眼试验。

A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.

机构信息

Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA.

出版信息

Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.

DOI:10.1016/j.ajo.2011.03.018
PMID:21704965
Abstract

PURPOSE

To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery.

DESIGN

Multicenter, randomized, contralateral-eye, double-masked trial.

METHODS

Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery.

RESULTS

Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011).

CONCLUSIONS

In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery.

摘要

目的

比较两种皮质类固醇对白内障手术后角膜厚度和视力的影响。

设计

多中心、随机、对侧眼、双盲试验。

方法

52 名患者(104 只眼)行双眼白内障超声乳化术。第一只眼随机接受双氯芬酸钠 0.05%或醋酸泼尼松龙 1%;另一只眼接受另一种药物。术前 2 小时内给予 7 剂;术后给予 3 剂,然后出院。当天余下时间,每 2 小时给予皮质类固醇一次,第 1 周每天 4 次,第 2 周每天 2 次。术前及术后第 1、15、30 天评估角膜厚度、视力和角膜水肿。术前及术后 30 天评估内皮细胞计数。术前及术后第 15、30 天评估视网膜厚度。

结果

第 1 天双氯芬酸钠治疗组角膜厚度减少 33μm(P=0.026)。第 1 天,双氯芬酸钠组无角膜水肿的眼数多于醋酸泼尼松龙组(分别为 62%和 38%;P=0.019)。第 1 天未矫正和最佳矫正视力均优于醋酸泼尼松龙,分别提高了 0.093 logMAR 线(P=0.041)和 0.134 logMAR 线(P<0.001)。第 30 天,双氯芬酸钠治疗组内皮细胞密度增加 195.52 个/平方毫米(P<0.001)。第 15 天,双氯芬酸钠治疗组视网膜厚度减少 7.74μm(P=0.011)。

结论

在这种高剂量脉冲治疗方案中,双氯芬酸钠比醋酸泼尼松龙更有效地减轻炎症,从而更快地恢复视力。白内障手术后,双氯芬酸钠在保护角膜和减少黄斑增厚方面更具优势。

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